Device for harvesting, processing and transferring adipose tissue

ABSTRACT

The present disclosure provides devices and methods for harvesting and processing tissue from patients for grafting. The devices can include a tissue collection chamber for ascetically collecting, processing, and/or re-implanting adipose tissue.

This application is a divisional of U.S. patent application Ser. No.15/013,111, filed Feb. 2, 2016; which is a continuation of U.S. patentapplication Ser. No. 13/894,912 filed May 15, 2013 and issued as U.S.Pat. No. 9,278,165; which claims the priority of U.S. ProvisionalApplication No. 61/653,011, filed May 30, 2012; all three applicationsof which are incorporated herein by reference in their entirety.

The present disclosure relates generally to devices and methods forharvesting and cleaning tissue.

Autologous fat transfer is a procedure that involves harvesting apatient's adipose tissue for implantation elsewhere in the patient'sbody. Adipose-tissue grafting involves a number of steps, which caninclude: collecting, processing, and/or implantation of the tissue.These steps may require fat to be transferred between instruments, whichcan present risks for infection, contamination, and tissue damage.

Accordingly, the present disclosure provides improved devices andmethods for collecting, processing, and/or reimplanting adipose tissueand/or other tissue types.

SUMMARY

A device for preparing tissue is provided. The device can comprise acontainer and a filter having a peripheral rim portion, wherein thefilter is positioned within the container such that the peripheral rimportion engages at least one inner surface of the container to define afirst tissue collection chamber and a second filtrate collectionchamber. The device can further comprise a flexible membrane, whereinthe edges of the flexible membrane are connected to at least one of aninner surface of the container within the peripheral rim portion and theperipheral rim portion of the filter to form a fluid-tight seal betweenat least a part of the at least one inner surface and the first tissuecollection chamber.

In certain embodiments, methods for preparing tissue are provided. Themethods can comprise transferring tissue from a patient to a device forharvesting, processing, and/or transferring tissue. The device cancomprise a container and a filter having a peripheral rim portion,wherein the filter is positioned within the container such that theperipheral rim portion engages at least one inner surface of thecontainer to define a first tissue collection chamber and a secondfiltrate collection chamber. The device can further comprise a flexiblemembrane, wherein the edges of the flexible membrane are connected to atleast one of an inner surface of the container within the peripheral rimportion and the peripheral rim portion of the filter to form afluid-tight seal between at least a part of the at least one innersurface and the first tissue collection chamber. The method can furthercomprise processing the tissue and causing the flexible membrane toexpand within the tissue collection chamber to apply pressure to thetissue within the first tissue collection chamber to transfer the tissueout of the tissue collection chamber. The method can further permit there-injection of treated tissue into the delivery instrument at aconstant pressure, thus reducing damage to the cells caused by theincrease of shear forces in the cannula.

DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of a device for processing tissue,according to certain embodiments of the present disclosure.

FIG. 2A illustrates a cut-away view of a device for processing tissue,according to certain embodiments of the present disclosure.

FIG. 2B illustrates a cross-sectional view of a device for processingtissue, according to certain embodiments of the present disclosure.

FIGS. 3 and 4 illustrate perspective views of two devices withalternative filter shapes, according to certain embodiments of thepresent disclosure.

FIG. 5 illustrates an enlarged view of a portion of a device forprocessing tissue, according to certain embodiments of the presentdisclosure.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Reference will now be made in detail to certain exemplary embodimentsaccording to the present disclosure, certain examples of which areillustrated in the accompanying drawings. Wherever possible, the samereference numbers will be used throughout the drawings to refer to thesame or like parts.

In this application, the use of the singular includes the plural unlessspecifically stated otherwise. Also in this application, the use of “or”means “and/or” unless stated otherwise. Furthermore, the use of the term“including,” as well as other forms, such as “includes” and “included,”are not limiting. Any range described herein will be understood toinclude the endpoints and all values between the end points.

In certain embodiments, the present disclosure provides devices andmethods for collecting, cleaning, concentrating, and/or preparingadipose tissue and/or other tissue types for implantation. The devicesand methods can reduce the risk of contamination and complicationsrelated to tissue-graft surgery. The devices and methods can provide asingle system for harvesting and processing of adipose tissue, whichhelps reduce surgical time, improves processed tissue quality, andreduces the risk of complications such as infection and/or graftfailure. In certain embodiments, the devices provide a single containerto aseptically collect, clean, concentrate, and/or transfer tissues.

Assemblies incorporating the devices and methods of use for asepticallyharvesting, processing, and/or transferring processed tissue forimplantation are also disclosed. The devices may be particularly usefulfor collecting, processing, and/or implanting adipose tissue, but thedevices may have applicability for other tissues and/or tissuesubstitutes (e.g., processed tissue matrices, collagenous materials, andcellular compositions.)

In one aspect, as shown in FIG. 1, the present disclosure is directed toa device 10 for collecting, cleaning, concentrating, and/or transferringtissue. The device 10 can comprise a container 20 and a filter 30 havinga peripheral rim portion 12. The filter 30 can be positioned within thecontainer 20 such that the peripheral rim portion 12 engages at leastone inner surface 14 of the container 20 to define a first tissuecollection chamber 50 within the filter 30 and a second filtratecollection chamber 60.

As discussed further below, the device 10 can include one or more ports70, 80. At least one port 70 can be in fluid communication with thetissue collection chamber 50. In some embodiments, an opening 74 (FIG.2b ) of the port 70 is within the tissue collection chamber 50. Duringuse, tissue may be drawn into the tissue collection chamber 50 throughthe port 70 and may be subsequently pushed out of the port 70 forreimplantation. Further, a second port 80 is in fluid communication withthe filtrate collection chamber 60 and can be attached to a suction lineto allow removal of fluids or undesirable materials from tissuecollected in the tissue collection chamber 50. In some embodiments, anopening 84 (FIG. 2B) of the port 80 is within the filtrate collectionchamber 60.

The device 10 can further include a flexible membrane 40 (illustrated inFIG. 2A), which can assist in transferring tissue out of the tissuecollection chamber 50. The flexible membrane 40 can also assist inremoving excess fluid or other undesirable materials from the tissuecontained in the tissue collection chamber 50. The flexible membrane 40can be positioned within the tissue collection chamber 50 such that theedges of the flexible membrane 40 are connected to at least one of aninner surface 14 of the container within the peripheral rim portion 12and the peripheral rim portion 12 of the filter 30 to form a fluid-tightseal between at least a part of the at least one inner surface 14 andthe first tissue collection chamber 50. In some embodiments, the atleast one inner surface 14 of the container or filter rim portion 12 mayhave an O-ring or similar component for sealing the edges. In variousembodiments, the flexible membrane 40 can be connected directly to thefilter rim portion 12, to the wall of the container within the filter'sinterior volume, to both the filter rim portion 12 and the wall of thecontainer, or to other supporting structures within the container.

In certain embodiments, the membrane 40 is made of a flexiblebiocompatible material. For example, the membrane 40 can made of anelastomeric material that expands during use, as described furtherbelow. Non-limiting examples of suitable materials include silicone, andthermoplastic elastomers.

The container 20 can have a variety of suitable sizes, shapes, andstructural features. The container 20 may have a shape and volume thatallow for the placement of a filter 30 inside, while providingsufficient space to allow collection of filtrate resulting from theprocessing and/or washing of the tissue within the tissue collectionchamber 50. In certain embodiments, the container 20 may be cubically orcylindrically shaped.

The container 20 can also be formed of a variety of different materials.Generally, the container 20 will be made of materials designed towithstand changes in pressure associated with processing tissue. Incertain embodiments, the container 20 may be made of biocompatibleand/or medical grade materials that can be sterilized as-needed. Incertain embodiments, at least a portion of the container 20 istransparent such that device operators may visually inspect the contentsof the device 10 during operation. Non-limiting examples of materialssuitable for the container 20 include glass, polycarbonate,polypropylene, polyethylene, styrene, stainless steel or titanium,chrome plate on any metal and rigid plastics. In certain embodiments,the device 10 may be configured such that it is elevated from the groundor working surface by legs 100 or similar elevation mechanisms, suchthat hoses, cannulae, tubing or similar parts may be attached to ports70, 80.

As discussed above, the device 10 can further include a filter 30. Thefilter may have a shape and volume that allow for its placement withinthe container 20, while providing sufficient space to allow collectionof the tissue and fat cells being processed and/or washed. In certainembodiments, the filter holds volumes ranging from about 50 cubiccentimeters to about 2000 cubic centimeters. The filter 30 may beselected to have openings or pores 32 (FIG. 2A) sized to retaincollected tissue within the tissue collection chamber 50, whilesimultaneously allowing the removal of excess liquids and undesirablematerials through the filtrate collection chamber 60. In certainembodiments, the size of the openings or pores are selected to allow theretention of viable groupings of adipose cells, while simultaneouslyallowing smaller components of the lipoaspirate, for example blood, freelipids, tumescent, wash solutions, collagen strands, and bust cellspass. In certain embodiments, the openings have a size ranging from 100μm to 3 mm. In certain embodiments, the openings 32 are of the same ordifferent sizes. In one embodiment, the filter may be a rigid meshscreen.

The filter 30 may be made of a rigid material designed to withstandpressures and/or pressure changes associated collecting, processing,and/or transferring tissues. In certain embodiments, the filter 30 maybe made of biocompatible and/or medical grade material. Non-limitingexamples of materials suitable for the filter 30 include metals, alloys,ceramics, and plastics. In one embodiment, the filter 30 is made ofstainless steel.

In certain embodiments, the shape of the filter is selected such thatits surface area in contact with the tissue is maximized to reduceclogging. In most embodiments, the filter is sized such that viablegroupings of adipose cells are maintained and smaller components of thelipoaspirate (blood, free lipids, tumescent, wash solutions, collagenstrands, bust cells) pass through the filter. For example, in certainembodiments the filter may have pores ranging from about 100 μm to about3 mm pore size. The filter 30 can be shaped to assist in transfer oftissue out of the tissue collection chamber 50 and/or to assist inwashing of tissue and/or removal of fluid (e.g., water from collectedtissues). For example, in one embodiment, the filter 30 is shaped toguide the tissue within the tissue collection chamber 50 toward anopening 74 (FIG. 2B) of the port 70 to aid the transfer of tissue forimplantation. The filter 30 can be shaped such that its cross-sectionalarea decreases towards the opening 74 of port 70. As such, thedecreasing cross-sectional area guides the tissue and/or cells towardsthe opening 74 for removal from the tissue collection chamber 50. Incertain embodiments, the filter 30 has a conical shape with across-sectional area that decreases towards the opening 74 of the port70. In certain embodiments, the filter 30 is connected to the port 70adjacent to the bottom of the device 10 to allow the introduction andremoval of tissues. Other suitable shapes may be selected to facilitatetransfer of tissue through the opening 74. For example, as shown in FIG.3, the filter 30′ may have a round bottom, but the filter can also bepyramidal, V-shaped, or have varying surface geometries.

In addition, other filter shapes may be used. For example, as shown inFIG. 4, the filter 30″ can be discoidal, or substantially flat. Inembodiments according to FIG. 4, the tissue collection chamber 50′ is influid communication with port 70 by a connecting tube 73. The connectingtube 73 may have a shape and volume that allow for the transfer oftissue in and out of the tissue collection chamber 50′. The tube 73 canbe made of a material that can withstand pressure changes typical of themethods according to the present disclosure. The tube 73 and the port 70may be made of biocompatible materials. In certain embodiments accordingto FIG. 4, the flexible membrane 40 can be connected directly to thewall of the container within the filter's interior volume.

As mentioned above, the devices of the present disclosure can furtherinclude a number of ports suitable for the transfer of tissue in and outof the device 10. The ports 70, 80 are suited with fittings made ofbiocompatible and/or medical grade materials that may withstand thepressure, temperature, flow rate and other process specifications. Theports can also be selected to allow the application of vacuum atdifferent times during the process. The size of the ports is selected toallow the removal of unwanted materials from the device.

The present disclosure further provides methods for collecting,processing, and/or transferring tissue using the devices and any oftheir variations, as described herein. During use, medical tubing may beattached to an end/opening 71 (FIG. 5) of the port 70 in communicationwith the tissue collection chamber 50. The tubing, not shown, mayfurther be connected to a cannula or liposuction instrument forcollection of adipose tissue from a patient. As shown, the port 70 mayhave two or more connectors/openings 71, 72 to accommodate multiplesurgical instrument connections and/or to provide variations inconnector sizes for different tube diameters or instruments.

In order to draw tissue into the tissue collection chamber 50, apressure differential between the tissue collection chamber 50 andexterior of the container (i.e., within the surgical tubing connected tothe port 70) is created. In one embodiment, the pressure differential iscreated by connecting a negative pressure source to another port influid connection with the container 20. For example, in one embodiment,a negative pressure source, such as a hospital vacuum line, is connectedto the port 80 in fluid connection with the filtrate collection chamber60. Other ports may be provided and used to produce the pressuredifferential to draw tissue into the tissue collection chamber 60.

Once a desired amount of tissue is collected, the tissue may beprocessed (e.g., washed, concentrated, partially dried) beforereimplantation, or the tissue may be implanted without furtherprocessing. In some embodiments, the tissue is washed one or more times.The tissue can be washed by contacting the tissue with fluid (e.g.,saline, ringer's lactate, detergents, collagenase, stem cells, pHbuffers.) The tissue can be contacted with fluid by transferring fluidinto the tissue collection chamber. In one embodiment, the fluid isinjected via the port 70. In that way, the fluid will serve to provide amixing effect to enhance cleaning. It will be appreciated, however, thatthe washing or processing fluids can be inserted through other ports,e.g. through an upper surface of the container 20.

After or simultaneous with injection of washing fluids, filtrate (e.g.,washing fluid and undesired materials in the tissue) can be removedthrough the filtrate collection chamber 60. In certain embodiments, thefiltrate is removed by applying negative pressure to one or more ports80 in communication with the filtrate collection chamber 60. It will beappreciated that a sloped or conical shaped filter can be beneficial byallowing removal of fluids through the filtrate collection chamber 60,while also assisting in directing tissue towards the opening 72 of port70 for reimplantation.

After washing, or instead of washing, tissue may be processed to removeexcess water and/or concentrate adipose cells. For example, in certainembodiments, additional negative pressure is used to pull a desiredamount of water out of tissue within the tissue collection chamber,thereby increasing the concentration of adipose cells available per unitvolume for implantation. After processing, the tissue can be transferredout of the tissue collection chamber 50 for reimplantation. A surgicalinstrument may be again connected to openings/connectors 71, 72 so thattissue can be transferred through the port 70 for reimplantation. Next,in order to facilitate transfer through the port 70, the flexiblemembrane 40 is caused to expand, thereby pushing the tissue towards theopening 74 of the port 70 and into an attached instrument forreimplantation. In addition, as the expanded membrane pushes the tissueagainst the walls of the filter, the excess fluid is removed from thetissue. In certain embodiments, a tube is connected to port 70 andfitted to a re-injection cannula and a valve. In certain embodiments, asthe membrane expands, it pushes the tissue through the tube andreinjection cannula appended to port 80. In certain embodiments, theprocess according to the present disclosure permits pushing the tissuefrom the filter through the cannula at a constant pressure.

The flexible membrane 40 can be caused to expand in a number of ways. Asdescribed above, the flexible membrane 40 can be connected to at leastone of an inner surface 14 of the container within the peripheral rimportion 12 and the peripheral rim portion 12 of the filter 30 to form afluid-tight seal between at least a part of the at least one innersurface 14 and the first tissue collection chamber 50. In addition, thedevice 10 can comprise at least one port 90 in fluid communication witha cavity or space 41 formed between the membrane and container wall orinner surface 14 (FIG. 2B). In some embodiments, an opening 94 of theport 90 is within the cavity/space 41. During transfer of tissue intothe tissue collection chamber 50, the port 90 may be closed. Duringtransfer of tissue out of the chamber, the port 90 may be opened toallow fluid and/or air to enter the cavity/space 41 to expand the cavityand flexible membrane.

Additional methods may be used to increase the expansion force of theflexible membrane 40 to allow transfer of tissue out of the tissuecollection chamber 50. For example, in one embodiment, negative pressureis again applied to the filtrate collection chamber 80 while the port 90is opened, thereby creating a reduced pressure within the container 20and causing the flexible membrane 40 to expand. In addition, oralternatively, pressurized fluid or air may be injected through the port90 and into the cavity/space 41 to force the flexible membrane 40 toexpand with a desire level of force.

It will be appreciated that expansion of the flexible membrane may alsobe used to facilitate tissue washing and removal of fluid. For example,in some embodiments, the opening 72 can be closed, and the flexiblemembrane 40 can be caused to expand to squeeze excess water or washingfluid out of tissue within the tissue collection chamber 60.

In certain embodiments, the method for harvesting, processing, andtransferring adipose tissue, as described herein, is carried out as asingle batch operation. In certain embodiments the method forharvesting, processing, and transferring adipose tissue, as describedherein, is carried as a continuous operation.

What is claimed is:
 1. A method for preparing tissue comprising:selecting a device comprising: a main container having at least oneinner surface and a bottom wall; a filter having a sloped wall and aperipheral rim portion, wherein the filter is positioned within the maincontainer such that the peripheral rim engages at least one innersurface of the main container to define a first tissue collectionchamber and a second filtrate collection chamber, and wherein the filtersloped wall is attached to the bottom wall; at least one port passingthrough a portion of the bottom wall and in fluid communication with thefirst tissue collection chamber and an exterior of the main container,the at least one port having an opening within the first tissuecollection chamber; and a flexible membrane attached at its periphery,the periphery of the flexible membrane attached to at least one of thefilter and the at least one inner surface of the main container todefine the first tissue collection chamber as a space between theflexible membrane and the sloped wall of the filter, and wherein theflexible membrane has sufficient flexibility to allow expansion of theflexible membrane into the first tissue collection chamber to force atleast a portion of a tissue that may be contained in the first tissuecollection chamber through the at least one port; transferring tissue tothe first tissue collection chamber; processing the tissue within thefirst tissue collection chamber; and causing the flexible membrane toexpand within the first tissue collection chamber to apply pressure tothe tissue within the first tissue collection chamber to transfer thetissue out of the first tissue collection chamber through the at leastone port in fluid communication with the first tissue collectionchamber.
 2. The method of claim 1, wherein transferring tissue to thefirst tissue collection chamber includes applying a suction pressure toat least one port in fluid communication with the device to draw tissueinto the first tissue collection chamber.
 3. The method of claim 2,wherein applying the suction pressure to at least one port to drawtissue into the first tissue collection chamber includes applyingnegative pressure to a port having an opening within the second filtratecollection chamber to produce a pressure differential between the firsttissue collection chamber and the at least one port having an openingwithin the first tissue collection chamber.
 4. The method of claim 1,wherein processing the tissue includes at least one of washing thetissue, concentrating the tissue, and removing a portion of watercontained in the tissue from the tissue.
 5. The method of claim 1,wherein processing the tissue includes washing the tissue by contactingthe tissue with a washing fluid.
 6. The method of claim 1, wherein themembrane is expanded by applying pressure to a space formed between theflexible membrane and the at least one inner surface of the container.7. The method of claim 1, wherein the membrane is expanded by creating apressure differential between an interior of the first tissue collectionchamber and a space formed between the flexible membrane and the atleast one inner surface of the main container.
 8. The method of claim 7,wherein the pressure differential is created by applying negativepressure to the interior of the chamber.
 9. The method of claim 1,further comprising removing water from the tissue prior to transferringthe tissue out of the first tissue collection chamber.
 10. The method ofclaim 9, wherein the water is collected in the second filtratecollection chamber.
 11. The method of claim 9, wherein the water isremoved by applying suction to the tissue in the first tissue collectionchamber.
 12. The method of claim 9, wherein the water is removed byexpanding the flexible membrane while the at least one port in fluidcommunication with the first tissue collection chamber is closed,thereby applying pressure to the tissue with the flexible membrane. 13.The method of claim 1, wherein the tissue comprises an adipose tissue.